Recall archive
46 recalls · page 1 of 2
Reported Aug 19, 2026Updated Sep 4, 2026
Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
Matched: Brand · Product details — Firmware issue potentially leading to loss of geometry movements.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 12, 2026
Philips Allura under the following System Descriptions and corresponding model numbers: 1. Allura Xper FD10; Model…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
Matched: Brand · Product · Product details — Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 24, 2026
Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 for MultiDiagnost Eleva; Model # 708034…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
Matched: Brand · Product · Product details · Reason for recall — Philips Allura Xper and MultiDiagnost-Eleva systems Hand switch button not fully releasing potentially leading to loss of imaging functionality or…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 10, 2026
Philips Azurion 3M12, Model Numbers: 722063, 722221 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
Matched: Brand · Product · Product details — During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user…
7 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 3, 2026
Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M15 (722064,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
Matched: Brand · Product · Product details · Reason for recall — It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six…
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 27, 2026
Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the below product descriptions…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
Matched: Brand · Product · Product details · Reason for recall — Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be impacted due to mechanical wear of the…
3 more products in this recall
FDA (openFDA device enforcement)
Reported May 20, 2026
Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
Matched: Brand · Product · Product details — Potential for the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to the monitor ceiling suspension may loosen and/or…
FDA (openFDA device enforcement)
Reported Apr 22, 2026
Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
Matched: Brand · Product · Product details · Reason for recall — Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (Interventional Tool). Philips has determined that the…
FDA (openFDA device enforcement)
Reported Apr 8, 2026
Allura Xper FD10C; System Code: 722001;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
Matched: Brand · Product · Product details · Reason for recall — Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
22 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 18, 2026
Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number - All versions: R1.X,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
Matched: Brand · Product · Product details — Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
7 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 28, 2026
Philips Azurion system; Software Version Number: R3.1;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
Matched: Brand · Product · Product details · Reason for recall — Philips has identified two (2) software issues affecting device systems that may result in loss of imaging (X-ray) functionality and/or loss of…
FDA (openFDA device enforcement)
Reported Jan 21, 2026
Product Name: Allura Xper FD10C; Model number: 722001;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
Matched: Brand · Reason for recall — Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field…
17 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 3, 2025
Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number: 722234;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
Matched: Brand · Product · Product details — The motorized longitudinal movement of the FlexArm stand may be inconsistent (not smooth) and eventually may become unavailable. This issue is due to…
FDA (openFDA device enforcement)
Reported Oct 29, 2025
Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
Matched: Brand · Product · Product details · Reason for recall — Over time some systems may experience loss of imaging functionality and/or poor image quality due to potential corrosion of the Image Intensifier…
FDA (openFDA device enforcement)
Reported Oct 8, 2025
Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
Matched: Brand · Reason for recall — The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the…
14 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 1, 2025
Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
Matched: Brand · Reason for recall — Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply…
12 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 17, 2025
IntelliSpace Cardiovascular, Software 8.0.0.4.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.V.
Matched: Brand — Software issue that results in the display of outdated information.
FDA (openFDA device enforcement)
Reported Sep 10, 2025
Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
Matched: Brand · Product · Product details · Reason for recall — Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) have the potential of shutting down and/or not…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 6, 2025
Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
Matched: Brand · Product · Product details — Potential for temporary loss of imaging (X-ray) functionality due to software issue.
FDA (openFDA device enforcement)
Reported Jul 30, 2025
Azurion 7 M20. Fluoroscopic X-Ray System.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
Matched: Brand · Product · Product details — Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose.
FDA (openFDA device enforcement)
Reported Jun 18, 2025
Azurion R1.x and R2.x systems; Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4) 722068, (5) 722078, (6) 722079,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
Matched: Brand · Product · Product details · Reason for recall — A software issue was identified in the internal communication process between the system software and the X-ray generator firmware. Loss of imaging…
FDA (openFDA device enforcement)
Reported May 21, 2025
Enterprise 1.5T, Model Number: 781145;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
Matched: Brand — The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose…
13 more products in this recall
FDA (openFDA device enforcement)
Reported May 14, 2025
IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.V.
Matched: Brand — An issue was identified with the software when using the Echo Module of ISCV, the issue may result in missing or incomplete information in the report.
FDA (openFDA device enforcement)
Reported Apr 30, 2025
Zenition 70. The device is to be used in health care facilities both inside and outside the operating room, sterile as…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.V.
Matched: Brand · Reason for recall — Philips has become aware of the potential for unintended radiation exposure with Zenition 70 systems with Vascular Extension option and a Wireless…
FDA (openFDA device enforcement)
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